FDA product code · General, Plastic Surgery
FXXMask, Surgical
Product code FXX covers Mask, Surgical, a Class II device regulated under 21 CFR 878.4040. FDA has cleared 607 devices in this code, 9 of them in the last 12 months. Median review time across the 607 most recent decisions is 128 days. openFDA lists 12 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 878.4040
- Review panel
- General, Plastic Surgery
- Clearances
- 607
What is happening in FXX right now?
FXX (Mask, Surgical) has two findings, most consequential first. 5 first-time filers in the last 12 months, including Zhejiang Hangkang Medical Equipment Co., Ltd. and Beatles Medical Supplies (Xiantao) Co., Ltd (K252534, K252830, K243342, K252941, K251902). The code is crowded, scoring 95 of 100 — 460 companies hold a clearance here and 9 arrived in the last 12 months (FXX:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K252534, K252830, K243342, K252941, K251902 |
| Crowding | Context | FXX:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in FXX?
FDA has cleared 607 devices under product code FXX since the 510(k) programme began in 1976, 9 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251967 | HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor | O&M Halyard, Inc. | |
| K252534 | Surgical Face Mask (Ear mount) | Zhejiang Hangkang Medical Equipment Co., Ltd. | |
| K253398 | Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) | Efofex, Inc. | |
| K252830 | Disposable Surgical Face Mask (3P00B, C2900) | Beatles Medical Supplies (Xiantao) Co., Ltd. | |
| K252650 | Disposable Medical Face Mask | Makrite Industries, Inc. | |
| K243342 | KP Protective Face Mask | Kp Trading Co., Ltd. | |
| K252941 | HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops | O&M Halyard, Inc. | |
| K252964 | PRIMED Surgical and Procedure Masks | Primed Medical Products, Inc. | |
| K251902 | Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) | Vitacore Industries, Inc. | |
| K250082 | Procedure mask/Surgical mask/Face mask | Winner Medical Co., Ltd. |
How long does FDA review take for FXX?
The median FDA review time for FXX is 128 days, measured across the 607 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in FXX?
openFDA lists 12 recall records against product code FXX. A recall record covers one firm's corrective action and may span many device lots.
Z-0728-2025Open, ClassifiedO&M Halyard, Inc.
Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.
Z-0729-2025Open, ClassifiedO&M Halyard, Inc.
Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.
Z-1146-2024Open, ClassifiedAMD Medicom Inc.
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
Z-1147-2024Open, ClassifiedAMD Medicom Inc.
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
Z-1148-2024Open, ClassifiedAMD Medicom Inc.
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
Showing the 5 most recently initiated of 12. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for FXX?
MAUDE holds 57 adverse-event reports naming product code FXX, 14 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in FXX unusual?
FXX does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history |
24 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
Who has entered FXX in the last year?
5 companies filed in FXX for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Zhejiang Hangkang Medical Equipment Co., Ltd. | K252534 | |
| Beatles Medical Supplies (Xiantao) Co., Ltd. | K252830 | |
| Kp Trading Co., Ltd. | K243342 | |
| O&M Halyard, Inc. | K252941 | |
| Vitacore Industries, Inc. | K251902 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in FXX?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in FXX?
Across the 607 most recent decisions, these applicants filed most often in FXX.
| Applicant | Recent clearances |
|---|---|
| Tecnol New Jersey Wound Care, Inc. | 11 |
| Owens & Minor (O&M) Halyard, Inc. | 8 |
| Anago, Inc. | 7 |
| Protectaide, Inc. | 7 |
| 3M Company | 6 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch FXX
Get an email the morning anything changes in FXX — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.